Quotas

The DEA limits the quantity of Schedule I and II controlled substances which may be
produced in the United States in any given calendar year. By utilizing available data on
sales and inventories of these controlled substances, and taking into account estimates of
drug usage provided by the FDA, the DEA establishes annual aggregate production quotas for
Schedule I and II controlled substances. The aggregate production quota is allocated among
the various manufacturers who are registered to manufacture the specific drug. The DEA
also allocates the amount of bulk drug that may be procured by those companies which
prepare the drug into dosage units.